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Betahistine Tablets
Betahistine Tablets

P150
P150
PACKAGE LEAFLET: INFORMATION FOR THE USER Taking Betahistine with food and drink
Betahistine 8 mg tablets Betahistine can be taken with or without food. However, Betahistine
can cause mild stomach problems (listed in section 4). Taking
Betahistine 16 mg tablets betahistine with food can help reduce stomach problems.
Betahistine 24 mg tablets
Pregnancy and, breast-feeding and fertility
Betahistine dihydrochloride
Do not take betahistine dihydrochloride tablets if you are pregnant
Read all of this leaflet carefully before you start taking this unless your doctor has decided that it is absolutely necessary. Ask
medicine because it contains important information for you. your doctor for advice.
- Keep this leaflet. You may need to read it again. Do not breast-feed while using betahistine dihydrochloride tablets
- If you have any further questions, ask your doctor or unless instructed by your doctor. It is not known if betahistine
pharmacist. passes into breast milk.
- This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are Driving and using machines
the same as yours. Betahistine is not likely to affect your ability to drive or use tools or
- If you get any side effects, talk to your doctor or pharmacist. machinery.
This includes any possible side effects not listed in this leaflet. However, remember that the disease for which you are being
See section 4. treated with Betahistine (Ménière's disease) can make you feel
dizzy or sick, and can affect your ability to drive and use machines.
What is in this leaflet
1. What Betahistine is and what it is used for 3. How to take Betahistine
2. What you need to know before you take Betahistine Always take this medicine exactly as your doctor or pharmacist has
3. How to take Betahistine told you. Check with your doctor or pharmacist if you are not sure.
4. Possible side effects Your doctor will adjust your dose, depending on your progress.
·
5. How to store Betahistine Keep taking your medicine. The medicine can take a while to
·
6. Contents of the pack and other information start to work.

1. What Betahistine is and what it is used for How to take Betahistine

Betahistine is a type of medicine called a “histamine analogue”. · Swallow the tablets with water.
Betahistine is used for: · Take the tablet with or after a meal. However, Betahistine can
cause mild stomach problems (listed in Section 4). Taking
Ménière's disease – the signs of this include: Betahistine with food can help reduce stomach problems.
· feeling dizzy (vertigo)
How much Betahistine to take
· ringing in the ears (tinnitus)
Always follow your doctor's instructions because your doctor might
· hearing loss or hearing difficulty
adjust your dose.
This medicine works by improving blood flow in the inner ear. This
lowers the build up of pressure. The usual dose is:

2. What you need to know before you take Betahistine Adults

The usual dose is 24 mg to 48 mg per day. 8 mg tablets: one or two
Do not take Betahistine
tablets three times a day.
· if you are allergic to betahistine or to any of the other
16 mg tablets: half or one tablet three times a day.
ingredients of this medicine (listed in section 6)
· if you have a pheochromocytoma, a rare tumour of the adrenal If you take more than one tablet each day, spread your tablets
gland evenly over the day. For example, take one tablet in the morning,
one at midday and one in the evening.
Warnings and precautions
Try to take your tablet at the same time each day. This will make
· if you have a stomach ulcer (peptic ulcer) sure that there is a steady amount of the medicine in your body.
· if you have asthma Taking at the same time will also help you remember to take your
· if you have nettle rash, skin rash or a cold in the nose caused tablets. Betahistine is not recommended for use in children.
by an allergy, since these complaints may be exacerbated.
If you take more Betahistine than you should
· if you have low blood pressure
If you or someone else takes too many Betahistine tablets (an
If you suffer from any of the above conditions, consult your doctor overdose), you may feel sick (nauseous), sleepy or have stomach
about whether you may take Betahistine tablets. pain. Talk to a doctor or go to a hospital immediately. Take the
These groups of patients should be monitored by a doctor during Betahistine pack with you.
treatment. If you forget to take Betahistine
Children Wait until you have to take your next dose. Do not take a double
Betahistine is not recommended for those under 18 years old. dose to make up for a forgotten tablet.

Other medicines and Bethisitine If you stop taking Betahistine

Tell your doctor or pharmacist if you are taking, have recently taken Keep taking your tablets until your doctor tells you to stop.
or might take any other medicines. Even when you start feeling better, your doctor may want you to
carry on taking the tablets for some time to make sure that the
In particular, tell your doctor or pharmacist if you are taking any of medicine has worked completely.
the following medicines:
If you have any further questions on the use of this medicine, ask
Anti-histamines – This is because in theory betahistine may not your doctor or pharmacist.
work properly. Also, betahistine may lower the effect of anti-
histamines. 4. Possible Side Effects
Monoamine-oxidase inhibitors (MAOIs) – used to treat depression Like all medicines, this medicine can cause side effects, although
or Parkinson's disease. These may increase the exposure of not everybody gets them. Very few adverse effects have been
betahistine. reported with betahistine.
If any of the above apply to you (or you are not sure), talk to your The following serious side effects may occur during treatment with
doctor or pharmacist before taking Betahistine. Betahistine:

Black
Allergic reactions: Betahistine 24 mg tablets
· a red or lumpy skin rash or inflamed itchy skin White to off-white round uncoated tablets debossed with 'X' and a
· swelling of your face, lips, tongue or neck break line on one side and '89' on the other side.
· a drop in your blood pressure The tablet can be divided into equal doses.
· loss of consciousness Betahistine Tablets are available in:
· difficulty breathing Blisters of Polyamide/ Aluminium/ PVC/ Aluminium:
If any of these side effects occur you should stop treatment 8 mg: 10, 20, 30, 50, 60, 84, 90, 100 & 120 tablets
immediately and contact your doctor.
16 mg: 10, 20, 30, 60, 84 & 90 tablets
Other side effects include: 24 mg: 10, 20, 30, 50, 60 & 90 tablets
Common (affects less than1 in 10 people): White opaque round HDPE bottle with polypropylene closure
· feeling sick (nausea) containing cotton coil: 30 and 1000 tablets.
· indigestion (dyspepsia)
Not all pack sizes may be marketed
· headache.
Marketing Authorisation Holder
Other side effects that have been reported with the use of
UK_ Milpharm Limited
betahistine
Ares Block, Odyssey Business Park
Mild stomach problems such as being sick (vomiting), stomach
pain, stomach swelling (abdominal distension) and bloating. Taking West End Road
betahistine with food can help reduce stomach problems. Ruislip HA4 6QD
Reporting of side effects United Kingdom
If you get any side effects, talk to your doctor, pharmacist or nurse. MT_ Aurobindo Pharma (Malta) Limited
This includes any possible side effects not listed in this leaflet. You Vault 14, Level 2, Valletta Waterfront
can also report side effects directly (see details below). By
reporting side effects you can help provide more information on the Floriana FRN 1913
safety of this medicine. Malta

Malta The United Kingdom Manufacturer

ADR Reporting Yellow Card Scheme APL Swift Services (Malta) Limited
The Medicines Authority Website: HF26, Hal Far Industrial Estate, Hal Far
Post-Licensing Directorate www.mhra.gov.uk/yellowcard Birzebbugia, BBG 3000
203 Level 3, Rue D'Argens Malta
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt or
e-mail: [email protected] Milpharm Limited
Ares Block, Odyssey Business Park
5. How to store Betahistine West End Road
Keep this medicine out of the sight and reach of children. Ruislip HA4 6QD
United Kingdom
This medicinal product does not require any special storage
conditions. This leaflet was last approved in 11/2016.
Do not use this medicine after the expiry date which is stated on
the label, carton, bottle after (EXP).The expiry date refers to the
last day of that month.

Do not throw away any medicines via wastewater or household

waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Betahistine contains
- The active substance is betahistine dihydrochloride.
Each tablet contains 8 mg betahistine dihydrochloride.
Each tablet contains 16 mg betahistine dihydrochloride.
Each tablet contains 24 mg betahistine dihydrochloride.
- The other ingredients are microcrystalline cellulose, mannitol,
povidone, crospovidone, citric acid anhydrous, colloidal
anhydrous silica, talc and stearic acid.

What Betahistine looks like and the contents of the pack

Tablet.

Betahistine 8 mg tablets
White to off-white round, flat uncoated tablets debossed with 'X' on
one side and '87' on the other side.

Betahistine 16 mg tablets
White to off-white round uncoated tablets debossed with 'X' and a
break line on one side and '88' on the other side.
The tablet can be divided into equal doses.